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PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)

2011年12月2日更新者：Universität des Saarlandes

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON Study) A Randomized Prospective MRI-based Trial.

To compare the incidence of new ischemic brain injury detected with magnetic resonance imaging (MRI) after carotid artery stenting in patients treated with and without proximal cerebral protection (Gore Flow Reversal System).

研究概览

地位

未知

条件

颈动脉狭窄

干预/治疗

详细说明

Primary Objective:

The purpose of this study is to compare the rate of new ischemic brain injury detectable on MRI after carotid artery stenting between patients treated with proximal cerebral protection (Gore Flow Reversal System) and without cerebral protection.

Secondary Objective:

Impact of MRI-morphology of atherosclerotic plaque to the rate of new hyperintense diffusion weighted imaging (DWI) lesion on the post-treatment scan and to the rate of ipsilateral stroke or death.

研究类型

介入性

注册 (预期的)

220

阶段

第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

德国
- Saarland
  - Homburg、Saarland、德国、66424
    - 招聘中
    - Department of Diagnostic and Interventional Neuroradiology
    - 副研究员：
      
      Christian Roth, MD
    - 接触：
      
      Panagiotis Papanagiotou, MD
      
      电话号码：24302 49684116
      
      邮箱：provenon.study@me.com
    - 接触：
      
      Christian Roth, MD
      
      电话号码：24302 49684116
      
      邮箱：provenon.study@me.com
    - 首席研究员：
      
      Wolfgang Reith, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

Male and female ≥ 18 years old;
Suitable/Eligible for carotid artery revascularization;
Significant artery stenosis in symptomatic patients defined as ≥ 50% of the artery diameter (%DS) or asymptomatic ≥ 80 %DS by angiography. Symptomatic is defined as a carotid artery stenosis associated with ipsilateral transient ischemic attack (TIA), amaurosis fugax, ischemic stroke or retinal infarction within 6 months prior to enrollment.
Adequate clinical conditions to perform DW-MRI.
Ability of the individual to understand the character and the consequences of clinical trial.
Signed and dated informed consent provided before the beginning of any intervention.
Negative pregnancy test (serum or urine) and contraception use for any woman of childbearing age. Systematic contraceptives (oral, implant, injection) and dia-phragm or condoms with spermicidal are considered reliable. Women who have undergone bilateral oophorectomy or/and hysterectomy or women status post-menopausal for at least two years are eligible for this trial.

Exclusion Criteria:

Intracranial hemorrhage, hemorrhagic stroke, or stroke with mass effect demonstrated on CT scan or MRI within 30 days of the index procedure.
Persisting ischemic stroke (defined as either a score > 15 on the NIH stroke scale, a Rankin score > 3 or a Barthel score < 60 measured within one week prior to study entry).
Intracranial mass lesion (i.e., abscess, tumor, or other infection).
peripheral vascular, supra-aortic or internal carotid artery tortuosity precluding the use of catheter-based techniques required for successful results.
Lactation.
Arterio-venous malformation in the territory of the target carotid artery.
Any disease or medication that affects local hemostasis,
Participation in other clinical trials during the present clinical trial or within the last month.
Medical or psychological condition that would not permit completion of the trial or signing of informed consent.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

主要用途：治疗
分配：随机化
介入模型：并行分配
屏蔽：无（打开标签）

手臂数量

武器和干预

参与者组/臂	干预/治疗
有源比较器：Carotid Artery Stenting without Protection Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and without embolic protection device	程序：Carotid Artery Stenting without Protection Carotid artery angioplasty and stenting without cerebral embolic protection
有源比较器：Carotid Artery Stenting with Proximal Protection Subjects will undergo carotid artery angioplasty and stenting with any CE-certificated carotid stent and with a proximal embolic protection device provided by the GORE Neuro Protection System	程序：Carotid Artery Stenting with Proximal Protection Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System

研究衡量的是什么？

主要结果指标

结果测量	大体时间
The detection rate of new hyper-intense DWI lesion on the post-treatment compared to the pretreatment MRI imaging 大体时间：Day 1-3	Day 1-3

次要结果测量

结果测量	措施说明	大体时间
Ipsilateral stroke (ischaemic stroke, intracerebral bleeding or both, with symptoms lasting more than 24 h) or death between treatment and 30 days after treatment 大体时间：Day 30		Day 30
Technical Success of the procedure 大体时间：Day 0	Subjects (both groups) who due to technical reaseons are unable to performe carotid artery stenting will be considered as technical failures. Subjects who are unable to tolerate flow reversal (in group 2) and have their procedures completed without embolic protection or other methods will be also considered as technical failures.	Day 0
Access site vascular complications, defined as need for surgical repair or blood transfusion 大体时间：Day 0-7		Day 0-7

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Universität des Saarlandes

调查人员

首席研究员：Wolfgang Reith, MD、Saarland University Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2011年5月1日

初级完成 (预期的)

2014年5月1日

研究完成 (预期的)

2014年6月1日

研究注册日期

首次提交

2011年3月30日

首先提交符合 QC 标准的

2011年4月6日

首次发布 (估计)

2011年4月8日

研究记录更新

最后更新发布 (估计)

2011年12月5日

上次提交的符合 QC 标准的更新

2011年12月2日

最后验证

2011年3月1日

PROximal Protection VErsus NON-Protection in Carotid Artery Stenting (PROVENON)